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FDA 510(k)

OPTICAL TRACKING SYSTEM (OTS)

K-Number: K974602 · 1998-04-21

ApplicantRadionics Software Applications, Inc.
Decision Date1998-04-21
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

OPTICAL TRACKING SYSTEM (OTS) is the device name listed in this FDA 510(k) record. The listed applicant is Radionics Software Applications, Inc.. It received FDA 510(k) clearance on 1998-04-21 under 510(k) number K974602. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPTICAL TRACKING SYSTEM (OTS)?

OPTICAL TRACKING SYSTEM (OTS) is a medical device that received FDA 510(k) clearance on 1998-04-21. The listed applicant is Radionics Software Applications, Inc.. The 510(k) number is K974602.

When did OPTICAL TRACKING SYSTEM (OTS) receive FDA 510(k) clearance?

OPTICAL TRACKING SYSTEM (OTS) received FDA 510(k) clearance on 1998-04-21, under 510(k) number K974602.

Who is the listed applicant for OPTICAL TRACKING SYSTEM (OTS)?

The FDA 510(k) record lists Radionics Software Applications, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OPTICAL TRACKING SYSTEM (OTS)?

The FDA product code for OPTICAL TRACKING SYSTEM (OTS) is HAW.

Related Clinical Trials

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Other records listing Radionics Software Applications, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K990326OPTICAL TRACKING SYSTEM MICROSCOPE MODULE II, MODEL OTS MMIIK972905XPLAN-1K964801OPTICAL TRACKING SYSTEM (OTS)K961844OPERATING ARM SYSTEM (OAS) [WITH CT AND MR IMAGES]K962155GILL-THOMAS-COSMAN(GTC) DENTAL TRAYK960071IMAGEFUSION

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Related Devices (Code: HAW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253856Geniant Cranial (Navigated Neurosurgical Positioning Robot)Koh Young Technology, Inc.K261932Leksell® Vantage Stereotactic SystemElekta Solutions ABK253663Zeta Navigation SystemZeta Surgical, Inc.K253379Stealth AXiS Cranial clinical applicationMedtronic Navigation, Inc.K231897NeuroAlign softwareMedivis, Inc.K251317SOLOPASS 2.0 SystemIntravent Medical Partners

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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